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Ubrogepant is well-tolerated and efficient for the therapy of a migraine assault when taken throughout the prodromal section, based on research findings printed within the journal The Lancet.
Ubrogepant is a small-molecule calcitonin gene-related peptide (CGRP) receptor antagonist that has been permitted for the therapy of acute migraine.
To guage the security and efficacy of ubrogepant use throughout the prodrome, researchers carried out a section 3, multicenter, randomized, double-blind, placebo-controlled, crossover trial (UBR Prodrome; ClinicalTrials.gov Identifier: NCT04492020) at 75 websites in america between 2020 to 2022. After a screening interval, a subset of sufferers (n=480) was randomly assigned to obtain 100 mg ubrogepant adopted by placebo or placebo adopted by ubrogepant to deal with a qualifying prodrome occasion with a 7-day wash-out interval between remedies. The first consequence was the absence of headache of reasonable or extreme depth inside 24 hours of therapy.
A complete of 4802 qualifying prodrome occasions have been reported by 920 members throughout the screening interval. The commonest prodromal signs included sensitivity to lights (57%), fatigue (50%), neck ache (42%), and dizziness (28%). Prodromal signs progressed to headache between 1 and 6 hours in ³75% of qualifying prodrome occasions.
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These outcomes emphasise [emphasize]the medical worth of figuring out the prodrome in individuals with migraine and spotlight an necessary alternative to intervene within the earliest section of a migraine assault …
Amongst sufferers who have been randomly assigned to placebo (n=247; imply age, 41.7; 97% Girls; 87% White) or ubrogepant (n=233; imply age, 42.9; 88% girls; 90% White), 43% and 47% had migraine with out aura, that they had skilled migraine for a median of 20.0 and 22.8 years, and 22% and 17% had a historical past of utilizing preventative migraine drugs, respectively.
General, 46% reported absence of reasonable or extreme headache inside 24 hours of taking ubrogepant in contrast with 29% after taking placebo. These charges indicated that ubrogepant higher prevented headache than placebo (odds ratio [OR], 2.09; 95% CI, 1.63-2.69; P <.0001).
Equally, ubrogepant was favored over placebo for secondary outcomes of absence of reasonable or extreme headache inside 48 hours (OR, 2.13; 95% CI, 1.63-2.78; P <.0001) and absence of any depth headache inside 24 hours (OR, 1.93; 95% CI, 1.39-2.66; P <.0001).
Any antagonistic occasion occurred amongst 17% after ubrogepant and 12% after placebo administration. The commonest antagonistic occasions after taking ubrogepant included nausea (5%), fatigue (3%), dizziness (2%), and somnolence (2%).
The most important limitation of this research was the truth that use of prodromal signs to foretell migraine onset stays controversial. Nevertheless, the screening interval discovered that almost all prodromal signs progressed to migraine inside 6 hours.
“These outcomes emphasise [emphasize] the medical worth of figuring out the prodrome in individuals with migraine and spotlight an necessary alternative to intervene within the earliest section of a migraine assault to stop development to the headache section, cut back incapacity, and enhance outcomes,” the researchers concluded.
Disclosures: This analysis was supported by AbbVie. Some research authors declared affiliations with biotech, pharmaceutical, and/or system firms. Please see the unique reference for a full record of disclosures.
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